With the globalization of pharmaceutical manufacturing and the increasing prevalence of drug- and biologic-device combination products, the FDA recognized the importance of harmonizing the Pharmaceutical CGMP regulation to the extent possible with other widely used quality management systems, including ISO 9000, non-U.S. pharmaceutical quality management requirements, and FDA’s own medical device quality system regulations.
In August 2002 the FDA launched a new initiative, Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach. The goals of the initiative are to focus on the greatest risks to public health in manufacturing procedures, to ensure that process and product quality standards do not impede innovation, and to apply a consistent approach to these issues across FDA.
In September 2004 the PAT (Process Analytical Technologies) document was issued by FDA to encourage early adoption of new technological advances in industry and to ensure that regulatory review, compliance, and inspection policies are based on state-of-the art pharmaceutical science.
In September 2006, the FDA issued the guidance document, Quality Systems Approach to Pharmaceutical CGMP Regulations. This guidance is part of FDA’s CGMPs for the 21st century initiative, and is intended to serve as a bridge between the 1978 CGMP regulations and current understanding of quality systems.
STAT-A-MATRIX is uniquely qualified to help organizations understand, establish and implement management systems that assure compliance with these regulatory initiatives. STAT-A-MATRIX has worked with numerous FDA-regulated organizations to develop quality systems that stress quality management, quality assurance, design control, and the use of risk management tools, in addition to the fundamental quality control requirements in FDA CGMPs.
STAT-A-MATRIX pharmaceutical industry specialists can help your organization understand and comply with the complex requirements of FDA’s CGMPs for finished pharmaceuticals (21 CFR Parts 210 and 211), PAT initiatives, ISO quality systems, and the International Conference on Harmonisation (ICH) guidance documents.
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